Epidemiologist, Real-World Evidence (Remote US)

ICA.ai • Arlington, VA

3d • Remote

About The Position

International Consulting Associates, Inc. (ICA, Inc.) is seeking a highly skilled Epidemiologist with solid expertise in healthcare data and real-world evidence (RWE) generation. The role involves working with various types of real-world data (RWD), particularly electronic health records (EHR) and administrative claims data. The RWE Epidemiologist will lead collaborations with clients and stakeholders on the use and evaluation of RWD to support evidence assessment for medical devices. A strong background in RWD analytics and the use of RWE in regulatory decision-making is essential. Prior experience in a fast-paced consulting environment is preferred. ICA, Inc. is a growing company focused on assisting government clients with evaluating and achieving their objectives, offering cutting-edge innovation and solutions. They support federal agencies and large government services primes in Research and Data Analysis, Advanced-Data Science, and Strategic Services, with multiple analytics and research programs across HHS. ICA fosters a collaborative, work-life balance-prioritized environment.

Requirements

• Hands-on experience conducting data curation activities and analysis of RWD data, including EHR and administrative claims data, with direct experience executing protocols.
• Master's degree in public health/Epidemiology required.
• Mastery of key considerations, principles, and best practices for RWE generation.
• Experienced with EHR and Claims data.
• Deep understanding of regulatory guidance and decision-making related to use of RWE.
• Ability to identify potential biases affecting RWD quality and reliability.
• Strong analytical, critical thinking and communication skills including technical writing and editing.
• Excellent writing skills/ability to summarize complex information in narrative form.
• Ability to work well alone or in small groups, as dictated by the project’s needs.
• Ability to meet client deadlines for deliverables.
• Ability to shift priorities while contributing to or leading multiple projects.
• Prior experience in working with external stakeholders.
• Demonstrated qualitative and analytical skills with a strong understanding of data management, statistical, and research methodologies.
• Must live in and be authorized to work in the United States.
• Must be able to obtain a Public Trust Clearance.

Nice To Haves

• Doctorate Degree in Epidemiology (preferred).
• Knowledge or expertise with pharmaceutical and health care device safety topics preferred.
• Previous experience working and/or collaborating with researchers from federal government agencies whose mission relates to public health (e.g., NIH, CDC, FDA, HRSA, or other HHS agencies).
• Prior experience working in a fast-paced consulting environment is preferred.

Responsibilities

• Understanding of RWD architecture, curation, and analysis methodologies across different types of health data to support scientifically robust and actionable research that aligns with regulatory expectations.
• Conduct assessments of varying scope on the relevance, reliability, quality, and feasibility of RWD sources to support RWE generation for regulatory decision-making.
• Independently deliver detailed assessments of key research, pre-market, and regulatory materials relevant to RWE generation for medical devices.
• Identify and evaluate data curation, architecture, and bias considerations for RWE conducted across multiple healthcare data types.
• Ensure understanding of client needs for a variety of client requests.
• Conduct reviews of peer-reviewed research and regulatory materials to evaluate feasibility for future RWD studies.
• Collaborate with epidemiologists, data scientists, and non-technical stakeholders on RWE initiatives.

Benefits

• Health Insurance - 100% employer-paid premiums – ICA covers the full cost of one of three offered medical plans
• Dental Insurance
• Vision insurance
• Health Spending Account
• Flexible Spending Account
• Life and Disability insurance
• 401(k) plan with company match
• Paid Time Off (Vacation, Sick Leave and Holidays)
• Education and Professional Development Assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior